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CTRI Number  CTRI/2023/11/060336 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 23/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effect of lavender oil and lemongrass oil on mental health and concentration in students with academic stress  
Scientific Title of Study   A comparative Study on effect of lavender oil and lemongrass oil on mental health and concentration in healthy individuals with academic stress 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Sugirtha 
Designation  MD Scholar  
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences  
Address  International Institute of Yoga and Naturopathy Medical Sciences Kamarajar nagarC Chengalpattu
Kamarajar nagar Chengalpattu
Kancheepuram
TAMIL NADU
603001
India 
Phone  7358249627  
Fax    
Email  sugirthakannan85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Pandiaraja 
Designation  BNYS MD (Naturopathy) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences  
Address  International Institute of Yoga and Naturopathy Medical Sciences Kamarajar nagar Chengalpattu
Kamarajar nagar Chengalpattu
Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrKSugirtha 
Designation  MD Scholar  
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences  
Address  International Institute of Yoga and Naturopathy Medical Sciences Kamarajar nagar Chengalpattu
Kamarajar nagar Chengalpattu
Kancheepuram
TAMIL NADU
603001
India 
Phone  7358249627  
Fax    
Email  sugirthakannan85@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences  
 
Primary Sponsor  
Name  DrKSugirtha 
Address  International Institute of Yoga and Naturopathy Medical Sciences Kamarajar nagar Chengalpattu-603001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sugirtha  International Institute of Yoga and Naturopathy Medical Sciences   Faculty block Department of hydrotherapy 1st floor Kamarajar nagar Chengalpattu -603001
Kancheepuram
TAMIL NADU 		 7358249627

sugirthakannan85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences Chengalpattu -603001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Academic stress  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lavender oil  The subjects will be asked to sit in a chair with hands on their knees with eyes closed in a silent & dark lighted room. The group 1 will inhale lavender oil in a closed room with the help of electric aroma oil diffuser.Subjects will receive ten minutes of intervention per day for the period of 30 days.  
Comparator Agent  Lemongrass oil   The subjects will be asked to sit in a chair with hands on their knees with eyes closed in a silent & dark lighted room. The group 2 will inhale lemongrass oil in a closed room with the help of electric aroma oil diffuser.Subjects will receive ten minutes of intervention per day for the period of 30 days.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects who are willing to participate in the study  
 
ExclusionCriteria 
Details  Subjects with Generalized anxiety disorder
Subjects with Major depressive disorder
Women during Pregnancy & lactation
Subjects with other co-morbidities
Subjects with head injury & Migraine
Subjects who are on Anti-Psychotic & Anti-epileptic medications
Subjects with learning disability
Subjects with developmental delay
Subjects with ENT Disorders
Subjects with claustrophobia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
DASS-21 – Depression anxiety stress scale
PSQI – Pittsburgh sleep quality index
SLCT – Six letter cancellation task
DLST - Digit letter substitution test 		 1st week
3rd week
6th week 
 
Secondary Outcome  
Outcome  TimePoints 
BP - Blood pressure
HR - Heart rate 		 1st week
3rd week
6th week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Online

  6. For how long will this data be available start date provided 24-11-2023 and end date provided 25-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction: 
  • Stress is an innate response of the body that may be either physical, mental, or emotional to an unforeseen event that occurs in the life of the individual. 
  • Academic life is one of the events in an individual’s life that may have different stressors. 
  • Contemporary literature suggests that university life is subjected to different stressors arising from academic pressure, social problems, and personal issues. 
  • It may also involve living away from the family which brings social isolation and adds to personal vulnerability. 
  • Negative mental health leads to decreased energy, difficulty thinking, concentrating, and making career decisions. Students are a pillar of the future in building an educated society. 
Aromatherapy: 
  • Aromatherapy is the popular complementary therapy that uses essential oils (also known volatile oils) from parts of the plants for the improvement of physical, emotional and spiritual well-being. 
  • Lavender and lemongrass oil as an herbal remedy has been associated with anxiolytic properties. 
  • It was suggested that the anxiolytic and antidepressant effects could be associated with the suppression of the activity of the sympathetic nervous system and it is perceived as pleasant and displays a relaxing activity, it has been employed in aromatherapy in different therapeutic contexts. 
Study design: 
  • A Comparative Pre-Post study design will be adopted for this study. All the eligible subjects will be divided into two groups, Lavender group and Lemongrass group. 
  • Group 1 will receive inhalation of Lavender oil for 10 minutes/day & Group 2 will receive inhalation of Lemongrass oil for 10 minutes/day for a period of 30 days. 
  • Assessments will be done before the intervention, 15th day and after the intervention of 30 days. 
Sample size : (n=100)

Randomization and Blinding:
  • Subjects will be randomly divided (1:1 ratio) into Lavender group and Lemongrass group. 
  • Allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique. 
  • Subjects and investigators will not be blinded in the study.
Primary Outcome:
  • DASS-21 – Depression anxiety stress scale
  • PSQI – Pittsburgh sleep quality index
  • SLCT – Six letter cancellation task
  • DLST - Digit letter substitution test
Secondary Outcome: 
  • BP – Blood pressure 
  • HR - Heart rate
 
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